FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0610
11-digit product format
002830610
Labeler code
0283
Product ID
0283-0610_5c90e595-a2ce-1246-e063-6294a90a0d5c
Type
HUMAN OTC DRUG
Nonproprietary name
Topical Anesthetic
Dosage form
SPRAY
Route
DENTAL; PERIODONTAL
Labeler
Beutlich Pharmaceuticals LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-15
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
HurriCaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0610-11HurriCaine2 in 1 BOXSPRAY229
0283-0610-26HurriCaine25 in 1 BOXSPRAY2529
0283-0610-43HurriCaine0.492 g in 1 APPLICATORSPRAY0.49229

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0610-11EA - Each0283-0610a0d290b2-6028-4065-83b2-182dbdb9548812013-02-13
0283-0610-26EA - Each0283-0610d76b6641-8bc7-4240-84eb-904f4aa9031912013-02-13
0283-0610-43EA - Each0283-0610449fbf46-3d69-4d5d-9500-e9bb98bbace712024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5HURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
CHERRYINACTIVE INGREDIENTBUC5I9595WHURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0610HURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]27Current NDC, Legacy NDC, 3 package rows20240208_255fba91-6357-4414-ad23-a18694ef886b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Whitening Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.c25b6a95-e604-48e3-bc55-595969d1ce9b2025-12-23WarningsExact identifier
application number: M022
parodontax Active Gum RepairSTANNOUS FLUORIDEHaleon US Holdings LLCb51ccdd9-c0af-4caa-ad97-ad1d1423b76b2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLC59bb84d6-6fd3-4586-bccf-7dc45cbbb39c2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLCf6912712-ce9b-44aa-8953-b9a8d420f4582025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair WhiteningSTANNOUS FLUORIDEHaleon US Holdings LLC817e804c-e55e-4d77-9ab9-ff54ae7947252025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair Breath FreshenerSTANNOUS FLUORIDEHaleon US Holdings LLCaddcb1e2-24b9-4367-adf3-6806e2439a802025-12-22WarningsExact identifier
application number: M022
parodontaxSTANNOUS FLUORIDEHaleon US Holdings LLC0f07aa1a-97be-44af-92d8-a10777e24e0a2025-12-22WarningsExact identifier
application number: M022
R B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.410c40fd-cf94-0301-e063-6294a90ae2de2025-12-18WarningsExact identifier
application number: M022
Dem ZeroPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.411f1a0f-ed02-cc78-e063-6394a90a0aec2025-12-18WarningsExact identifier
application number: M022
Res B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.21469f58-1d70-774f-e063-6294a90af0392025-12-18WarningsExact identifier
application number: M022
Alzh LPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.41056de0-aaa2-01bb-e063-6394a90af7b82025-12-18WarningsExact identifier
application number: M022
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
application number: M022
CloSYSHYDROGEN PEROXIDERowpar Pharmaceuticals, Inc.299fc7b1-af6d-4bf9-810f-d35283423fe22025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.c13761e0-d45d-4e0f-ac41-428e005f96bb2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.6dca566b-cb6a-43c4-b6e2-f2bad77fb9322025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.7ede08e5-2dfe-4183-905d-28d1cea424072025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.9de36e4f-f966-4a58-b4bf-9ac3b86b3f092025-12-17WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDECVS PHARMACY, INC3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb22025-12-17WarningsExact identifier
application number: M022
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360348benzocaine 20 % Mucosal SprayPSN255fba91-6357-4414-ad23-a18694ef886b29
808357HurriCaine 20 % Mucosal SprayPSN255fba91-6357-4414-ad23-a18694ef886b29
808357benzocaine 200 MG/ML Mucosal Spray [Hurricaine]SBD255fba91-6357-4414-ad23-a18694ef886b29
360348benzocaine 200 MG/ML Mucosal SpraySCD255fba91-6357-4414-ad23-a18694ef886b29
360348benzocaine 20 % Mucosal SpraySY255fba91-6357-4414-ad23-a18694ef886b29
808357Hurricaine 20 % Mucosal SpraySY255fba91-6357-4414-ad23-a18694ef886b29
808357Hurricaine 200 MG/ML Mucosal SpraySY255fba91-6357-4414-ad23-a18694ef886b29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0610-11002830610112 APPLICATOR in 1 BOX (0283-0610-11) / .492 g in 1 APPLICATOR (0283-0610-43) 2 applicator2016-04-010000-00-00NoNoCurrent
0283-0610-260028306102625 APPLICATOR in 1 BOX (0283-0610-26) / .492 g in 1 APPLICATOR (0283-0610-43) 25 applicator2016-04-010000-00-00NoNoCurrent
0283-0610-43002830610430.492 g in 1 APPLICATOR0.492 gHistorical